NCT07848750Recruiting
InstaSure™ Non-Invasive Finger-Press Test for Hepatocellular Carcinoma
InstaSure™ Non-Invasive Finger-Press Point-of-Care Screening Test for Hepatocellular Carcinoma
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
This prospective observational case-control study evaluates the InstaSure™ Non-Invasive Finger-Press Test for hepatocellular carcinoma (HCC). The study plans to enroll 40 participants, including 30 patients with HCC, 5 patients with benign liver disease, and 5 healthy controls. Finger-tip skin cell samples will be collected non-invasively and tested for HCC-associated CCND1 and CDKN2A/P16 eccDNA signals. The primary objective is to preliminarily evaluate the sensitivity and specificity of the test in distinguishing patients with HCC from non-HCC controls. The study will also assess the feasibility of the testing procedure and explore the association between eccDNA signals and clinical characteristics of HCC, providing preliminary data for subsequent larger-scale clinical studies.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 40 (estimated)
- First submitted
- 19 Sept 2026
- Start date
- 30 Jun 2026
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Beijing Municipal Administration of Hospitals
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07848750
What you commit to
- Study type: Observational
- Planned participants: 40
- From 30 Jun 2026 to the primary completion date, 1 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History or current diagnosis of other pathologically confirmed malignancies, except for malignancies treated with curative intent and without recurrence for more than 5 years.
- Receipt of blood transfusion, immunosuppressive therapy, or other interventions that may significantly affect interpretation of the test results within 1 month before enrollment.
- Receipt of chemotherapy within 3 months before enrollment, or receipt within 1 month before enrollment of other anticancer treatment that may affect interpretation of nucleic acid signal testing results, including but not limited to targeted therapy, immunotherapy, or tumor radiotherapy.
- Benign Liver Disease Group:
- History or current diagnosis of a pathologically confirmed malignancy, except for malignancies treated with curative intent and without recurrence for more than 5 years.
- History or current diagnosis of a pathologically confirmed malignancy, except for malignancies treated with curative intent and without recurrence for more than 5 years.
Other illness
- Severe systemic diseases, including but not limited to severe cardiac, pulmonary, or renal insufficiency, or uncontrolled acute systemic infection.
- Conditions affecting standardized fingertip sampling, including but not limited to severe skin lesions, fingertip injury, or inability to complete the standardized sampling procedure.
- Any other condition that, in the investigator's judgment, may affect interpretation of the study results or participant safety.
- Severe cardiac, pulmonary, or renal insufficiency, including New York Heart Association (NYHA) functional class III or higher heart failure or chronic kidney disease requiring regular dialysis.
- Severe infection or active bleeding.
- Mental or cognitive impairment resulting in inability to understand or sign the informed consent form.
- Severe cardiac, pulmonary, or renal insufficiency, including New York Heart Association (NYHA) functional class III or higher heart failure or chronic kidney disease requiring regular dialysis.
- Severe infection or active bleeding.
- Mental or cognitive impairment resulting in inability to understand or sign the informed consent form.
- Recent history of liver disease.
Other
- HCC Group:
- Pregnant or breastfeeding women.
- Poor compliance or inability to understand the study, cooperate with study procedures, or complete the study procedures as expected.
- Pregnant or breastfeeding women.
- Current participation in another interventional clinical trial.
- Healthy Control Group:
- Pregnant or breastfeeding women.
- Current participation in another interventional clinical trial.
Who the study is looking for
- HCC Group:
- Age ≥18 years, with no restriction on sex.
- Primary hepatocellular carcinoma (HCC) confirmed by histopathology or clinical imaging according to the diagnostic criteria specified in the National Health Commission Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2026 Edition).
- Benign Liver Disease Group:
- \* Age ≥18 years, with no restriction on sex, with a clinical diagnosis of benign liver disease and hepatocellular carcinoma (HCC) excluded.
- Healthy Control Group:
- Age ≥18 years, with no restriction on sex.
- No history of liver disease, with normal liver function tests and liver ultrasonography.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Ditan Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.